Steerable sphincterotome and methods for cannulation, papillotomy and sphincterotomy

ABSTRACT

The present invention relates to methods and devices for performing endoscopic cannulation, papillotomy and sphincterotomy and similar procedures. According to the present state of the art, endoscopic cannulation of the common bile duct and papillotomy and similar procedures are accomplished by advancing the device into an endoscope/duodenoscope so that the distal tip of the device exits the endoscope adjacent the sphincter muscles at the Papilla of Vater. The endoscope mechanisms are then manipulated to orient the distal tip of the device to the desired position for proper cannulation of the duct. Due to inconsistencies in, for example, the sphincterotome, anatomy, and endoscope manipulation, it is difficult to accurately and consistently position the sphincterotome for proper cannulation. The steerable sphincterotome of the present invention allows the physician to control the position of the distal tip of the device independently of the endoscope and adjust for inconsistencies in the device and the anatomy. According to the present invention, the handle to which the cutting wire is attached is freely rotatable relative to the catheter. The handle, secured to the cutting wire but rotatable relative to the shaft of the catheter, provides a mechanism to rotate the wire, transmitting the force to rotate the device tip. With the handle rotating independently of the shaft at the proximal end, the force can be applied directly to the distal tip without twisting the entire shaft. Also a rotation lock to maintain the orientation of the tip and/or a rotation marking, to indicate the amount of rotation may be included.

This application is a continuation of previously filed U.S. patentapplication Ser. No. 09/928,655, filed Aug. 14, 2001, entitled“STEERABLE SPHINCTEROTOME AND METHODS FOR CANNULATION, PAPILLOTOMY ANDSPHINCTEROTOMY”, issued Jan. 13, 2004, U.S. Pat. No. 6,676,659, whichclaims priority to U.S. Provisional Application No. 60/224,981 filed onAug. 14, 2000.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention generally relates to apparatus that is useful inperforming diagnostic and therapeutic modalities in the biliary tree andmore particularly to apparatus that is adapted for facilitating thediagnosis of gallstones in the bile duct and other portions of thebiliary tree and the removal of such gallstones.

2. Description of Related Art

Historically the migration of gallstones into an individual's commonbile duct was corrected by general surgical procedures. A surgeon wouldincise the bile duct and remove the gallstones and normally remove thegallbladder. In recent years less invasive treatment modalities havereplaced these general surgical procedures and reduced patient trauma,long hospital stays and recovery periods.

For example, U.S. Pat. Nos. 4,696,668 and 4,781,677, both to Wilcox,disclose a treatment modality involving the administration of adissolution agent in the bile duct to essentially dissolve anygallstones. More specifically, a catheter contains several lumens forinflating and deflating each of two balloons, venting bile, and infusingand aspirating the dissolution agent. Inflating the balloons occludesthe bile duct at two spaced sites and creates a sealed spaced thatreceives the dissolution agent. As the space is sealed from theremaining biliary tree, the dissolution agent finds access to thegallbladder and any gallstones therein through the cystic duct with theexclusion of bile from the gallbladder fundus. The dissolution agentalso will be confined in high concentration around bile duct gallstones.After the gallstones dissolve the balloons are deflated and the cathetercan be withdrawn. In this particular approach, the catheter is directedinto the biliary tree using a standard duodenoscope that passes throughthe alimentary tract. Although this and analogous approaches have thepotential of minimizing patient trauma, such treatments require extendedplacement of the duodenoscope in the patient, exhibit low efficacy andintroduce a potential for adverse reactions to the dissolution agents.

In an alternative approach, a surgeon directs a surgical extractor intothe biliary tree through at least an incision in the bile duct. Forexample, in U.S. Pat. No. 3,108,593 to Glassman a surgeon incises boththe bile duct and duodenum. Then the surgeon directs an extractorthrough the bile duct incision, biliary tree, sphincter of Oddi andduodenum to exit through the duodenum incision. This extractor includesa series of longitudinally spaced cages for trapping any gallstones inthe bile duct and removing them through either of the incisions.

U.S. Pat. No. 4,627,837 to Gonzalo discloses a catheter device with apair of inflatable balloons at its distal end. This catheter is ledthrough an incision in the bile duct toward the duodenum. After thedistal balloon passes through the sphincter of Oddi, both balloons areexpanded to anchor the catheter in place. This enables the catheter tobe used for irrigating and flushing through other lumens in order tocapture any gallstone in the second balloon for removal through theincised bile duct.

In accordance with still another modality as for the treatment ofstrictures, a surgeon may insert a catheter device through the bile ductor duodenum for the purpose of dilating or enlarging the sphincter ofOddi. For example, U.S. Pat. No. 4,705,041 to Kim discloses a dilatorthat is directed through an incision in the bile duct and the sphincterof Oddi. An expandable tip dilates the sphincter of Oddi. U.S. Pat. No.5,035,696 to Rydell discloses an electrosurgical instrument that isdirected through the duodenum and to the sphincter of Oddi forperforming a sphincterotomy. This apparatus contains a cutting wire thatis heated to cut the sphincter muscle. U.S. Pat. No. 5,024,617 toKarpiel, discloses a similar device that can be directed through aduodenoscope. U.S. Pat. No. 5,152,772 to Sewell, Jr. discloses a devicefor performing a sphincterotomy that is directed through an incision inthe bile duct and includes a knife for cutting the sphincter muscle.

The use of the duodenoscope and sphincterotomy devices, such as shown inthe Rydell and Karpiel patents, enables an internist to diagnose andtreat problems in the biliary tree with minimal patient invasion. Forexample, modalities as described in these patents eliminates the surgeryneeded for incising the bile duct. Consequently, these modalities can beperformed as outpatient or day surgical procedures. These proceduresgreatly reduce patient trauma, the length of a hospital stay andrecovery times. For example, if an internist determines that gallstonesare present in the biliary tree, particularly the common bile duct, theinternist can insert a duodenoscope into the duodenum to view thesphincter of Oddi. Then a first catheter can be advanced through theworking channel of the duodenoscope with or without a guidewire anddirected through the sphincter of Oddi into the biliary tree. Contrastagent injected through the catheter enables fluoroscopy or other imagingprocedures to confirm the presence of gallstones within the biliarytree. Next the internist exchanges the first catheter for a secondcatheter for performing a sphincterotomy such as the types disclosed inthe above-identified Rydell and Karpiel patents. The second catheter isthen exchanged for a third catheter such as shown in the Glassman patentor some other equivalent retrieval catheter for drawings gallstonesthrough the enlarged sphincter of Oddi. Thereafter the retrievalcatheter is manipulated to release the gallstone into the duodenum. Thecatheter, any guidewire and the duodenoscope can then be removed tocomplete the procedure.

This procedure is significantly less traumatic to the patient than otherprior art procedures because the only incision occurs during thesphincterotomy. However, this procedure as presently practiced requiresthree separate catheters and two catheter exchanges. These exchanges arerequired because the first, second and third catheters function solelyto inject contrast agent to perform the sphincterotomy and to dislodgegallstones, respectively. The time required for performing each catheterexchange can increase patient trauma and increase the duration of theprocedure and reduce efficiency. Moreover, each such procedure requiresthe use of two or three separate catheter devices.

SUMMARY

Therefore, an object of this invention is to provide apparatus forperforming both diagnosis and additional therapeutic treatment withoutrequiring a catheter exchange.

Yet another object of this invention is to provide apparatus thatenables the removal of gallstones from the biliary tree by a procedurethat reduces the number of required catheters and catheter exchanges.

Still another object of this invention is to provide a single catheterapparatus that can perform a sphincterotomy and remove gallstones in thecommon bile duct.

Yet another object of this invention is to provide a single catheterapparatus that can perform a sphincterotomy and inject contrast materialinto the biliary tree.

Still yet another object of this invention is to provide a singlecatheter apparatus that can inject contrast agent into the biliary tree,performing a sphincterotomy and remove gallstones in the bile duct intothe duodenum.

Presently available products that may be modified according to thepresent invention include the Boston Scientific Ultratome, Ultratome XL,Stonetome, Flourotome, Tapertome, RX “C” Channel Sphincterotome, RX “U”Channel Sphincterotome, and RX Tapertome. Other products that may bemodified according to the present invention include the Wilson CookCanulatome, Wiltex Accuratome, Bard ProForma, and Olympus CleverClevercut.

Accordingly, there is provided according to the present invention amethod for cannulation of a common bile duct comprising threading acatheter through an appropriately placed endoscope, wherein saidcatheter comprises at least two and preferably three lumens, preferablya guide wire lumen, a contrast lumen, and a cutting wire lumen, wherebythe handle of the device, secured to the cutting wire, may rotateindependently of the catheter shaft and whereby the handle assembly isrotated to change the position of the distal tip independently of thescope position to achieve desired position for cannulation of the commonbile duct. A rotation marking may be used to indicate the amount ofrotation present and a rotation lock may be used to maintain theorientation of the tip.

The present invention also provides a method for sphincterotomy, wherebyfollowing cannulation, the handle of the mechanism may be rotated again,to the extent necessary to achieve the desired cutting position andcutting is effected by application of current to the cutting wire.Rotation lock and rotation markings may also be incorporated.

According to the invention, there is also provided a device comprising acatheter comprising two or preferably three lumens, preferably a guidewire lumen, a contrast fluid lumen, and a cutting wire lumen, wherebythe catheter is rotatably attached to a handle fixed to the proximal endof the cutting wire. The proximal end of the catheter may terminate in amolded luer port assembly comprising entry points for the guide wire andfor injection of contrast fluid. The guide wire and contrast lumensterminate at the distal end of the catheter. The handle and the catheteror molded luer port assembly may be designed to snap together tofacilitate fast and inexpensive manufacture. Rotation lock and markingsmay also be included in this embodiment.

The present invention is an improvement of the devices and methodsdisclosed in U.S. Pat. Nos. 5,547,469, 5,868,698 and U.S. Pat. No.5,683,362 and in U.S. patent application Ser. No. 09/154,834 in the nameof Rowland, et al., all owned by the owner of the present application,the common disclosure of which is incorporated herein and the subjectmatter of which is considered part of the present invention as set forthbelow. FIGS. 1 and 2 herein are original to the present application.Accordingly, original FIGS. 1-9 of the Rowland, et al. applications arerenumbered herein as FIGS. 3 through 11.

In accordance with one aspect of this invention, apparatus can be usedin a treatment modality including an enlargement procedure and anotherprocedure to be performed. This apparatus includes a catheter withproximal and distal ends and proximal and distal portions. The catheterincludes first, second and third generally parallel lumens. The firstlumen has a greater diameter than either of the second and third lumensand the lumens each extend between proximal and distal portions of thecatheter. The apparatus for performing the enlargement procedure extendsthrough the second lumen for operating distally of the catheter inresponse to manipulations of an operator at the proximal end of thecatheter. The first lumen has a proximal port for enabling access to thefirst lumen and the third lumen has a proximal port and a distal portfor enabling the remote control of some other procedure.

In accordance with another aspect of this invention, apparatus isprovided for removing objects from the biliary tree. This apparatusincludes a catheter that is directed through the working channel of aduodenoscope and the sphincter of Oddi into the biliary tree. Thecatheter includes first, second and third lumens with the first lumenbeing larger than either the second or third lumens and the lumensgenerally extending between proximal and distal portions of the catheteralong parallel axes. Apparatus for cutting the sphincter of Oddiincludes a cutting wire extending through the second lumen andexternally of the catheter means through a distal port along a lengththat is coextensive with part of the distal portion of the catheter. Ahandle attaches to the catheter at the proximal portion and to theproximal wire portion to control the position and orientation of thecutting wire. A rotation lock and marking may be incorporated to fix theorientation of the distal tip and to indicate the orientation of thedistal tip respectively. An expansible balloon is mounted on the distalportion spaced from the cutting wire and can be inflated through thethird lumen in order to move any gallstone in the biliary tree throughthe enlarged sphincter of Oddi.

In accordance with still another aspect of this invention, the apparatusis provided for directing contrast agent into the biliary tree andperforming a sphincterotomy through the working channel of aduodenoscope. This apparatus includes a catheter that is directedthrough the working channel of the duodenoscope and the sphincter ofOddi into the biliary tree. The catheter includes first, second andthird lumens with the first lumen being larger than either the second orthird lumens and the lumens generally extending between proximal anddistal portions of the catheter along parallel axes. Apparatus forcutting the sphincter of Oddi includes a cutting wire extending throughthe second lumen and externally of the catheter means through a distalport along a length that is coextensive with part of said distal portionof the catheter. A handle attaches to the catheter into the proximalwire portion to control the position and orientation of the cuttingwire. A rotation lock and marking may be incorporated to fix theorientation of the distal tip and to indicate the orientation of thedistal tip respectively. The proximal port of the third lumen connectsto a contrast agent source and the third lumen delivers contrast agentinto the biliary tree through a distal port in the distal end of thecatheter.

BRIEF DESCRIPTION OF THE DRAWINGS

The various objects, advantages and novel features of this inventionwill be more fully apparent from a reading of the following detaileddescription in conjunction with the accompanying drawings in which likereference numerals refer to like parts, and in which:

FIG. 1 is a plan view of one embodiment of apparatus constructed inaccordance with the present invention with a rotatable handle attachedto a cutting wire;

FIG. 1 a is a plan view of a snap in handle connection for the apparatusof FIG. 1;

FIG. 2 is a view of an alternative embodiment of the rotatable handle ofthe present invention;

FIG. 3 is a plan view of one embodiment of apparatus constructed inaccordance with this invention;

FIG. 4 is a cross-section taken along lines 2-2 in FIG. 3;

FIG. 5 is a cross-section taken along lines 3-3 in FIG. 4;

FIG. 6 is a cross-section taken along lines 4-4 in FIG. 5;

FIG. 7 depicts the apparatus of FIG. 3 positioned through a duodenoscopefor injecting contrast agent into the biliary tree.

FIG. 8 is an enlarged view that depicts the orientation of the apparatusin FIG. 3 for performing a sphincterotomy;

FIG. 9 depicts the apparatus of FIG. 3 positioned through a duodenoscopefor dislodging material within the common bile duct;

FIG. 10 is a cross-section of an alternative embodiment of the apparatusas viewed generally along lines 3-3 in FIG. 4;

FIG. 11 is a cross-section of still another embodiment of this inventiontaken along lines 3-3 in FIG. 4;

FIG. 12 is a view of the rotatable handle of the present inventionincluding a rotation lock;

FIG. 13 is a detailed view of the rotation lock of FIG. 12;

FIG. 13 a is a sectional view along line A-A of FIG. 13;

FIG. 14 shows an alignment between the rotatable handle and thebifurcation connector showing zero rotation of the rotatable handle;

FIGS. 15 a-d show alternative embodiments of the rotation lock of thepresent invention;

FIGS. 16 a-d show cross-sectional areas of the alternate embodiment ofFIGS. 15 a-d;

FIGS. 17 a-c show three alternative embodiments of rotation markings forthe present invention;

FIGS. 18 a & b illustrate alternatives of bifurcation connectors; and

FIGS. 19 a & b illustrate a bowing lock included in the presentinvention.

DESCRIPTION OF ILLUSTRATED EMBODIMENTS

FIG. 3 depicts a catheter apparatus 10 that has the capability ofinjecting a contrast agent into the biliary tree, of performing asphincterotomy and of dislodging a gallstone into the duodenum. Theapparatus 10 includes a catheter 11 which, for purposes of definition,includes a proximal end portion 13 extending from a proximal end 12 anda distal end 14 with a distal portion 15 extending a short distance fromthe distal end 14. In a typical application, the catheter will have aworking length of 200 cm and the distal end portion 15 will have alength of 6 cm to 9 cm. Normally the distal portion 15 will have adiameter that is smaller than the diameter of the proximal portion toincrease the flexibility of the distal portion 15. The reduction indiameter also makes the tip less traumatic and allows the tip portion toreach smaller passages while allowing the larger proximal portion toprovide necessary hoop strength and rigidity, particularly where theproximal portion 13 is coextensive with the working channel of aduodenoscope. For example, the proximal and distal portions might havediameters corresponding to 7 Fr and 5.5 Fr catheter sizes (i.e., 0.09″and 0.07″ respectively).

As shown particularly in FIG. 4, the catheter 11 has three lumens. Afirst lumen 16 has a diameter that is greater than either a second lumen17 or a third lumen 20. In one particular embodiment the lumen 16 has adiameter of 0.040″ in the proximal portion 13 that reduces to about0.037″ in the distal portion 15 to receive a standard 0.035″ guidewire.In addition the lumen 16 is offset from the center of the catheter 11.

The lumens 17 and 20 are each smaller in diameter than the lumen 16 andare radially offset from the centerline of the catheter, from each otherand from the lumen 16. In one particular embodiment the lumens 17 and 20each have internal diameters of 0.028″ in the proximal portions 13 thatreduces to about 0.020″ in the distal portion 15. As described later,this lumen 20 carries a cutting wire for performing a sphincterotomy andfor allowing the infusion of a contrast agent at reasonable rates. Theangular spacing between the lumens 17 and 20 is about 45 degrees and theangular spacing between the first lumen 16 and each of the lumens 17 and20 each is about 157.5 degrees. In this configuration and with thesedimensions the proximal portion 13 readily passes through the workingchannel of any duodenoscope.

Referring again to FIGS. 3 and 4, each of the lumens 16, 17 and 20includes an entry port in the proximal portion 13 and an exit port inthe distal portion 15. Generally, and as described in more detail later,the first lumen 16 has an exit port through the distal end 14 while theexit ports for the lumens 17 and 20 can be sited at different locationsin the distal portion 15 depending upon a particular application.

In FIG. 3, the entry ports in proximal portion 13 adjacent the proximalend 12 include an entry port 21 that provides access to the lumen 16 andincludes an optional Leur lock fitting 22. A proximally positioned entryport 23 provides access to the lumen 17 and includes an optional Leurlock fitting 24. A proximal entry port 25 for the lumen 20 is locatedcoextensively with a portion of a handle 26 attached to the proximal end12.

Referring to the distal end portion 15, the catheter 11 in thisparticular embodiment carries an expansible balloon 30 proximally of theexcursion of a cutting wire 31 externally of the catheter 11. As shownin FIG. 5, the lumen 17 emerges at a distal exit port 32 through theside of the catheter 11 with the interior of the expansible balloon 30.An extension of the lumen 17 beyond the distal port 32 is sealed byknown, methods of manufacture. Consequently, fluid forced through theentrance port 23, as by a syringe (not shown) attached to the Leur lockfitting 24, expands the balloon 30 into an occluding orientation asshown in FIG. 5 with an inflated diameter in the range up to 20 mm.

As will also be apparent from viewing FIGS. 5 and 6, the first lumen 16extends through the catheter 11 and terminates with an exit port 33 inthe distal end 14. Thus the lumen 16 is adapted for receiving aguidewire through the entrance port 21 that will extend through thecatheter 11 and exit the distal end 14 and allow the catheter to slideover that guidewire.

Referring to FIG. 6, a distal end 34 of the cutting wire 31 attaches toa clamp 35 formed at the distal end of the lumen 20. Spaced skived ports36A and 36B allow an active portion 37 of the cutting wire 31 to emergefrom the catheter 11 through the skived aperture 36A, parallel thecatheter 11 exteriorly thereof and return into the lumen 20 through theport 36B and a reinforcing sleeve 38. The cutting wire 31 then extendsthrough the lumen 20 to the handle 26 shown in FIG. 1 where it emergesas a proximal end portion 40.

The handle 26, as shown in FIG. 3, includes a central member 41terminating with a thumb ring 42. The central member 41 extends throughand slides with respect to a body section 43 having opposed finger rings44. The central member 41 also attaches to the catheter 11, and istherefore an extension of the catheter 11. The member 43 additionallyincludes an internal connector 45 for clamping the proximal end 40 ofthe cutting wire 31. Thus, when the body 43 is at its distal position asshown in FIG. 3, the distal portion of the catheter 15 is in essentiallystraight line as shown in FIG. 3 with the active portion 37 of thecutting wire 31 being closely adjacent the catheter 11. Retracting thebody portion 43, causes the cutting wire 31 to bend the distal endupwardly as shown in FIG. 3 to a position that is essentially at rightangles to the main axis of the catheter, as will be shown later.

The connector block 45 and the cutting wire 31 are generally conductivemembers that attach through an RF connector 46 to an RF heating source47. The use of such RF heating sources 47 for energizing a cutting wire31 thereby to cut the sphincter muscle is well known in the art andrepresents one possible sphincterotomy procedure that can be adapted forthe apparatus of this invention and is not described further.

With this description of the apparatus structure, it will now bepossible to understand its use in a particular application. FIG. 7discloses, in a partially broken and schematic view, the positioning ofa duodenoscope 50 in the duodenum 51 adjacent the sphincter of Oddi 52.A catheter 11 such as constructed in FIG. 3 passes through the sphincterof Oddi 52 into the common bile duct 53, bypassing the pancreatic duct54. The distal end 14 does not extend to the gallbladder 55.

Fluoroscopy allows the appropriate positioning by utilizing a series ofradio-opaque markers 56 at the distal portion 15 that may include theclamp 35 and the reinforcing sleeve 38 in FIG. 6. The catheter 11 can bepositioned with or without the presence of a guidewire 57 in the lumen16 shown in FIGS. 4, 5 and 6. For purposes of injecting the contrastagent, any guidewire 57 can be withdrawn to allow the contrast agent tobe injected through the lumen 16 for purposes of fluoroscopicexamination to confirm the presence of one or more gallstones 58. It isalso possible during the operation to expand the balloon 30 to occludethe bile duct 53 and block any migration of contrast agent into theduodenum 51 or the pancreatic duct 54.

FIG. 8 is an enlarged view showing the duodenum 51, sphincter of Oddi52, portions of the pancreatic duct 54 and the common bile duct 53. InFIG. 8 the catheter 11 has been positioned relative to the duodenoscope50 through the opening of the sphincter of Oddi 52. The handle 43 inFIG. 3 has been drawn proximally to deflect the distal portion 15 intoessentially a right angle configuration such that the cutting wire 31abuts a portion of the sphincter of Oddi 52. The application of RFheating to the cutting wire 31 then will cut the sphincter of Oddi 52and enlarge the opening therethrough. As will be apparent, thesphincterotomy is performed with direct visualization of the sphincterof Oddi through the duodenoscope.

Moreover, as has been observed by others, catheters having guidewire andcutting wire lumens tend to assume a particular angular orientation whenthe distal portion 15 emerges from the duodenoscope. This orientation isessentially independent of, the angular position of the catheter when itis inserted into the duodenoscope. The offset nature of the lumen 20 asshown in FIG. 4, improves the location of the cutting wire 31 as thedistal portion 15 passes through the sphincter of Oddi 52. Specificallythe angularly offset brings the cutting wire 31 into better alignmentwith the common bile duct 53 and displaces the cutting wire from thepancreatic duct 54.

FIG. 9 depicts the catheter after the sphincterotomy and after thecatheter 11 is advanced over the guidewire 57, if used. FIG. 9 alsodiscloses the catheter 11 after the balloon 30 has been moved beyond agallstone 58 in the bile duct 53. The balloon 30 is expanded so thatupon withdrawal of the catheter 11 the balloon 30 will dislodge thegallstones 58 and sweep them through the sphincter of Oddi 52 into theduodenum 51.

As will now be apparent from the description of the particular catheterapparatus 10 shown in FIG. 3 and its use as discussed with respect toFIGS. 7, 8, and 9, the single catheter apparatus of this invention iscapable of providing diagnostic contrast agent injection, of performinga sphincterotomy and of dislodging gallstones in the common bile duct orother portions of the biliary tree without having to exchange acatheter. Moreover, positioning and sizing of the lumens enables thesefunctions to be performed with a catheter apparatus that is readilyadapted for use in the working channels of standard duodenoscopes.Consequently the gallstones can be removed from the biliary tree withoutbile duct incisions and accompanying surgical procedures, asduodenoscope can be introduced through the alimentary tract.Consequently the entire procedure is adapted for being performed morerapidly than prior art procedures and with fewer components. The neteffect is to reduce patient trauma and the overall time and cost ofconducting the procedure.

In FIG. 3 the balloon 30 is located proximally of the cutting wire 31.FIG. 10 discloses an alternative embodiment in which a balloon 60 islocated distally of the cutting wire 31. More specifically, the distalend of a lumen 17A, corresponding to the lumen 17 in FIGS. 5 and 6, issealed. A side facing exit port 61 skived or otherwise formed in thecatheter 11, opens into a chamber 62 formed by the balloon 60. A firstsealing portion 63 and a sealing portion 64 of the balloon 60 connectproximally and distally of the aperture 61 respectively and seal thechamber 62.

Introduction of a balloon inflation fluid through the lumen 17A expandsthe balloon 60 into an occluding orientation corresponding to theorientation of the balloon 30 shown in FIG. 5. Retraction of thecatheter 11 with the distal balloon 60 inflated enables withdrawal of agallstone from the bile duct. This particular embodiment is particularlyadapted when it is determined that a gallstone is located high in thebiliary tree to minimize the incursion of the distal portion 15 throughthe biliary tree beyond the gallstone or in any application in which theinternist desires to minimize the length of the distal portion 15 thatextends beyond the occluding balloon.

FIG. 11 discloses another embodiment of this invention for enlarging thesphincter of Oddi and performing another procedure, such as injecting acontrast agent into the biliary tree, as might be used in the diagnosisand treatment of a stricture in the biliary tree. In this particularembodiment an exit port 65 from the lumen 17B is located in the distalend 14 of the distal portion 15. The lumen 16 then can be used for aguidewire and the lumen 17B, for injecting the contrast agent directlyinto the biliary tree while the guidewire remains in place. Theapparatus would then be positioned to perform a sphincterotomy withouthaving to exchange a catheter should the procedure be warranted.

As still another alternative, the internist could utilize a conventionalcatheter for purposes of injecting the contrast agent to determine theneed for gallstone removal. If treatment were indicated, the internistcould then utilize apparatus as shown in FIG. 3 with a single exchangeover the guidewire that would pass through the lumen 16 as previouslydescribed.

Therefore, it will now be apparent that apparatus constructed inaccordance with this invention attains the several objects and theadvantages of this invention. More particularly, catheter apparatusconstructed in accordance with this invention allows the injection of acontrast agent, the performance of a sphincterotomy and dislodginggallstones from the common bile duct through the enlarged sphincter ofOddi into the duodenum all without requiring any catheter exchanges.Moreover, this apparatus allows such a procedure to occur through aduodenoscope to minimize patient trauma. The use of a single catheterwith an elimination of catheter exchanges further reduces the time andcosts associated with the use of multiple, single-function catheterdevices.

As will be apparent from the foregoing description, many alterations canbe made to the specifically disclosed embodiments. Different balloonstructures can be used and located at alternative positions. Differentcutting wire embodiments and orientations can be used. Thus, althoughthis invention has been disclosed in terms of certain embodiments, itwill be apparent that many modifications can be made to the disclosedapparatus without departing from the invention. In particular, it isconsidered that all of the foregoing embodiments may be used inconjunction with a handle fixed to the cutting wire but rotatablerelative to the catheter. A rotation lock fixing the orientation of thecutting wire and/or a rotation marking, indicating the amount ofrotation may be included with the current invention. Therefore, it isthe intent of the appended claims to cover all such variations andmodifications as come within the true spirit and scope of thisinvention.

Consistent therewith, the following subject matter claimed in theRowland, et al patents and applications is specifically claimed inconnection with the subject matter specific to the present application,namely, a handle fixed to the cutting wire and rotatable relative to theshaft of the catheter, whereby turning of the handle independently ofthe catheter and independently of the endoscope causes the distal tip ofthe device to rotate independently of the endoscope allowing thesurgical team greater control over the position of the device forcannulation and subsequently for sphincterotomy A rotation lock fixingthe orientation of the cutting wire and/or a rotation marking,indicating the amount of rotation may be included with the currentinvention.

Due to inconsistencies in the sphincterotome, anatomy, and endoscopemanipulation, it is difficult to accurately and consistently positionthe sphincterotome for proper cannulation. The steerable sphincterotomeof the present invention allows the physician to control the position ofthe distal tip of the device independently of the endoscope and adjustfor inconsistencies in the device and the anatomy. According to thepresent invention, the handle to which the cutting wire is attached isfreely rotatable relative to the catheter. Rotating the handle of thepresent invention induces a twisting of the attached cutting wire whichallows orientation of the distal end without rotating the proximal endof the attached catheter. See FIGS. 1 and 2. Handle 66, secured to thecutting wire at 80 but rotatable relative to the shaft of the catheterat 81, provides a mechanism to rotate the wire, transmitting the forceto rotate the device tip. With the handle rotating independently of theshaft at the proximal end, the force can be applied directly to thedistal tip without twisting the entire shaft. Also a rotation lock tomaintain the orientation of the tip and/or a rotation marking, toindicate the amount of rotation may be included. An integrated moldedluer port assembly for 2 and 3 lumen catheters may be provided to snapinto the rotatable handle, to facilitate fast and economicalmanufacturing, as shown in FIGS. 1 and 1 a. Alternatively, prior artserial lumen ports may be configured to snap into the rotatable handleas shown in FIG. 2.

Referring to FIG. 12, the present invention also contains a featureknown as a rotation lock. Rotation lock 68 allows the user to maintainthe orientation of the tip at all times. This is done by maintaining theposition of handle 66 relative to bifurcation connector 67 after thehandle has been rotated. Rotation lock 68 allows the user to releasehandle 66 at any time during the procedure, while maintaining theorientation of handle 66 and preventing further rotation while the lockis engaged. Maintaining the position of handle 66 maintains theorientation of the distal tip in the desired orientation. Maintainingthe orientation of the distal tip reduces the amount of time and effortrequired to cannulate if the distal tip moved. Preventing undesiredmovement of the distal tip may also prevent patient injury.

Referring to FIG. 13, two pair of mating detents 69 and slots 70 may beused to create this rotation lock. Detents 69 and slots 70 are locatedalong the central axis of body 71, at the intersection of body 71 andbifurcation connector 67. In FIG. 13, the two pair of detents 69 andslots 70 are located 180° apart, relative to the central axis. Thiscreates a lock position every half rotation of handle 66. During use ofthe device, as handle 66 is rotated, detents 69 become disengaged fromslots 70. As detents 69 become disengaged, they compress slightly. Ashandle 66 reaches a position 180° from where rotation began, detents 69recover from their compressed state, and engage with slots 70 onceagain. As detents 69 traverse from one position to the next, there is anoticeable amount of friction between the mating components. Thisfriction is great enough that handle 66 can be released at any timewithout fear of losing the orientation position of the distal tip.

Rotation lock 68 also serves a secondary function of keeping the distaltip locked in the home position while the catheter is being removed fromthe package, inserted into the endoscope, and manipulated through theendoscope. Without this feature, the initial orientation position of thedistal tip would become unpredictable. FIG. 13 a shows a detaileddiagram of the interaction between detents 69 and slots 70.

Referring to FIG. 14, when detents 69 and slots 70 are engaged,bifurcation connector 67 and finger rings 44 all lie in the same plane.This acts as the rotation marker. Whenever finder rings 44 are rotatedinto the same plane as bifurcation connector 67, the rotation lock isengaged, thus signaling 180° of rotation from the last position. The useof a marker such as this allows the user to more easily keep track ofhow much handle 66 has been rotated. This is helpful if the user desiresto move the distal tip back to its original position. In effect, theuser will know, for example, that handle 66 has been rotated threeclicks from the original position. Therefore, to return handle 66 to theoriginal position, it must be rotated three clicks in the oppositedirection.

FIGS. 15 a-15 d show alternative embodiments of rotation lock 68. FIG.15 a shows a pure frictional lock. The connection of bifurcationconnector 69 to the handle 66 could be designed such that rotation lock68 is purely a function of frictional interference between the twocomponents. Alternative embodiments could include different types ofassembly joints to create this friction. In the primary embodiment, theassembly of the two components is accomplished by mating a male post ofthe bifurcation connector to a female hole of the same size and shape.Alternative embodiments could reverse this, so that the male protrusionis part of the main body of handle 66. The friction lock could also bebuilt into the mating faces of main body and bifurcation connector,which are perpendicular to the major axis. FIG. 16 a shows a crosssection of the rotation lock along Z-Z of FIG. 15 a.

FIG. 15 b shows a oval post lock embodiment of the present invention.The connection of bifurcation connector 67 to handle 66 could also bedesigned incorporating an ovalized male post 73 and female hole 72. Inthis embodiment, as, handle 66 is rotated relative to bifurcationconnector 67, ovalized hole 72 would deform, allowing oval post 73 torotate. As handle 66 reached a rotation of 180°, ovalized hole 72 wouldconform back to its original shape, thus locking handle 66 in place. Asshown in FIGS. 15 c and 15 d, this basic concept may be expanded toincorporate other shapes rather than oval as shown in FIG. 15 b. One ofordinary skill in the art would appreciate that the shape of thegeometry however, governs the degrees of rotation between lockedpositions. For example, if post 73 and ovalized hole 72 configurationwere made up of mating equilateral triangles (FIG. 15 c), there would be120° of rotation between locked positions. Using a square configuration(FIG. 15 d), would give 90° between locked positions. FIG. 16 b,illustrates the cross-sectional area across Y-Y of FIG. 15 b. FIG. 16 cillustrates the cross-sectional area of FIG. 15 c across X-X and FIG. 16d illustrates the cross-sectional area of FIG. 15 d along cross-sectionW-W.

FIGS. 17 a-c show alternative embodiments by which a rotation marker maybe created and included in the present invention. One of ordinary skillin the art would understand these embodiments may be expanded. To aidthe user in knowing exactly how much handle 66 has been rotated from itsoriginal and/or last position, several forms of visual markers can beincorporated into the design. One alternative embodiment is comprised ofa set of lines placed radially, around the major axis, at the area wherethe main body and bifurcation connector 67 meets (FIG. 17 a). A singleline on the stationary component, bifurcation connector 67, would matchup with a corresponding line on body 43. As handle 66 is rotatedrelative to bifurcation connector 67, the series of lines on the bodywould rotate past the stationary line on bifurcation 67. Each line wouldindicate an incremental amount of movement. For example, if there werefour, equally spaced lines on the body, each line that passed the markeron the bifurcation connection would signify 90° of rotation.

This feature could be further enhanced by many methods. A series ofnumbers rather than lines could be used to signify the amount ofrotation (FIG. 17 b). Alternating colors could also be used to signifythe amount of rotation. Alternating line patterns could be used as well(FIG. 17 c).

Another alternative embodiment may use audible tones to make the useraware of the amount of rotation. One method for doing this would be ableto design the rotation lock features so that a click is clearly audibleat predetermined points along the rotational travel of the body.

Referring to FIGS. 18 a and 18 b, there are several alternative means bywhich a bifurcation connector can be created. One of ordinary skillwould understand these embodiments may be expanded from those presentedin the current application.

Although the present invention is comprised of a connector with twolumens, the connector design could easily be modified to accommodatethree or more lumens (FIG. 18 a). This would allow future designs toincorporate both guidewire post connector 74 and injection portconnector 75 into one component.

Another alternative to the bifurcation connector of the present designwould be one, which also houses the electrical connector 76 (FIG. 18 b).Electrical connector 76, presently incorporated into the finger ring,could be moved to the bifurcation connector.

Referring now to FIGS. 19 a and 19 b, other embodiments of the presentinvention may consist of handle 66 similar to that previously described,but with the addition of a bowing lock. A bowing lock would aid the userin that handle 66 could be released at any time, and the catheter tipwould maintain its bowed position. Just as the rotation lock providesfor a safer and more efficient procedure, the bowing lock would do thesame.

The bowing lock could be incorporated into the design in many ways. Thebowing lock, in its simplest form, would consist of friction lock 77created between finger rings 44 and main body 43 (FIG. 19 a). Analternative to this design would create a similar friction lock, butwould use the surfaces between wire termination 78 and main body 43(FIG. 19 b). The friction lock shown in FIG. 19 b is enhanced byincorporating several lock ribs 79. Lock ribs 79 would be used to holdthe catheter tip at a specific, predetermined angle. In effect, lockinghandle 66 into the first position would, for example, deflect the tip30°. The next position would deflect the tip 60°. This feature wouldgive the user even more control when positioning the catheter tip withinthe anatomy. In both cases, as finger rings 44 are actuated along mainbody 43, and catheter tip 80 is bowed, the friction between the matingcomponents would hold the position of the handle, and thus hold theposition of the bow.

1. A method of cutting tissue in a body passage comprising selecting acatheter having a first lumen configured for receiving a wire guide, asecond lumen configured for receiving an electrosurgical cutting wire,positioning said catheter in said passage at a desired position using anendoscope, actuating the electrosurgical cutting wire in the secondlumen, the improvement comprising: orientating said electrosurgicalcutting wire by rotating a handle relative to a proximal end of saidcatheter, said electrosurgical cutting wire also rotationallyorientating a distal portion of said catheter.
 2. The method of claim 1wherein said cutting wire is affixed to said handle, wherein said stepof rotating said handle causes a rotation of a proximal end of saidcutting wire whereby said cutting wire is caused to rotate within saidsecond lumen.
 3. The method of claim 1 further comprising: inhibitingfurther rotation of said handle relative to said proximal end of saidcatheter by engaging a rotation lock.
 4. The method of claim 1, furthercomprising: indicating an amount of rotation of said handle relative tosaid proximal end of said catheter through the use of a rotationindicator.
 5. The method of claim 4, wherein said step of indicating anamount of rotation includes a visual indication of said amount ofrotation.
 6. A catheter handle assembly comprising: a catheter handle; acatheter; a rotatable coupling connecting said catheter handle to aproximal end of said catheter, said rotatable coupling configured toallow free rotation of the proximal end of said catheter with respect tosaid catheter handle; a handle clamping member affixed to said catheterhandle and also affixed to a proximal end of a device, said deviceextending through a lumen formed in said catheter to a distal end ofsaid catheter where said device is affixed to said catheter, wherebyrotation of said catheter handle causes rotation of a proximal end ofsaid device in said lumen, and said rotation of a proximal end of saiddevice causes rotational orientation of the distal end of said catheter.7. The catheter handle assembly of claim 6, wherein said devicecomprises a cutting wire extending from said handle clamping memberwhere said cutting wire is affixed to said catheter handle and saidcutting wire also extending to a connection at a distal end of saidcatheter where said cutting wire is affixed.
 8. The catheter handleassembly of claim 6, further comprising: a rotation lock engageable toinhibit a rotation of said catheter handle with respect to said proximalend of said catheter.
 9. The catheter handle assembly of claim 6,further comprising: a rotation indicator configured to indicate anamount of rotation of said catheter handle relative to said proximal endof said catheter.
 10. The catheter handle assembly of claim 9, whereinsaid rotation indicator comprises a visual indicator of said amount ofrotation.